The U.S. Food and Drug Administration approved a prefilled syringe for self-injection of the allergic diseases treatment Xolair developed by Novartis and Genentech, a Roche company.

The U.S. Food and Drug Administration granted Novartis’ ligelizumab (QGE031) Breakthrough Therapy designation for the treatment of chronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria (CIU), in patients who have an inadequate response to H1-antihistamine treatment.

Ironwood Pharmaceuticals Inc. and Allergan plc announced that the companies reached an agreement with Mylan Pharmaceuticals Inc. resolving patent litigations brought in response to Mylan’s abbreviated new drug applications seeking approval to market generic versions of Linzess (linaclotide) before the expiration of the companies’ applicable patents.

The FDA approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes for Genentech’s Xolair as an additional formulation for allergic asthma and chronic idiopathic urticaria.